Best Practices Spotlight

[Editor's note: In this issue of Clinical Trials Administrator we begin a regular feature about best practices in the research industry. Our debuts focuses on the novel and successful subject recruitment and retention practices of Southeast Regional Research Group of Columbus, GA. If your site has a best practice you'd like us to highlight in a future issue, please contact editor Melinda Young at or by calling (864) 241-4449.]

Southeast Regional Research Group treats clinical trials like a business

Referrals remain high, enrollment is fast

Southeast Regional Research Group of Columbus, GA, starts serious discussions about where clinical trial participants can be found even before the new trial begins.

"Our advertising and marketing department discusses where we will get patients and which advertising we need," says Jeff Kingsley, DO, chief executive officer of the organization, which has five active research sites in Georgia and Alabama.

Start-up speed is crucial to successful enrollment, he says.

"The clinical trials industry is moving toward more globalization because they can find patients and cut costs," Kingsley says.

But moving trials overseas is a lot of hassle and requires extensive legal work, and this means that U.S. investigators have an opportunity to increase their business if they adopt strategies that lead to faster enrollment, he notes.

"I view this trend as a sign that we're dropping the ball," Kingsley says. "We need to ask ourselves why we can't give the industry the most benefit and what we need to do to retain the business the industry needs."

Southeast Regional Research Group has adopted professional strategies for each step of the clinical trial process to improve efficiency, enroll faster, and to operate as a business.

"If a sponsor and CRO [clinical research organization] are looking for a fast start-up too, we can be up on a study in two weeks," Kingsley says.

In an industry where about a third of trial sites never enroll a single subject, Southeast Regional's own track record is that easily 80-90% of trials meet enrollment deadlines, Kingsley notes.

"We typically go way over enrollment goals," he says. "If a sponsor wants 10 patients, I make sure there is not a cap, and I get pre-authorization to go over that number; I can come up with 60 patients if they want 10."

While improving enrollment is a top priority, it's also important to retain the patients who do enroll, Kingsley says.

To keep those patients in the study, investigators and CR staff go to great lengths, including personally visiting patients who have missed visits.

The organization uses these specific strategies and practices to improve enrollment:

• Customize marketing approach for each referral source: "When we meet with a new physician we find out who really runs the office," Kingsley says. "We find out who we should contact, and we create a database that has information about whether they prefer telephone calls, faxes, or e-mails."

Once this information is collected, it's used to tailor the marketing pitch and recruitment strategies to each referral source's business, he adds.

Even the thank you is tailored to the source: "We send the ERs pizza and coffee, and on holidays, we send them special food," Kingsley says. "On Christmas Day we sent BBQ to the ERs as something unique."

The organization has even sent sushi to the ER.

"They thought that was the neatest thing in the world," Kingsley says. "We also send them thank you notes when we get a referral, and these are written both personally and typewritten."

Southeast Regional also provides referral sources with tools that make it easier to refer patients. For example, there are tear-off sheets customized for the referral sources, Kingsley says.

"The sheets give directions from the ER to our doorstep, and we have directions for the local urgent care center to our doorstep," he adds.

The marketing department staff regularly speaks with physicians and physician assistants about upcoming trials.

"We say, 'When you see your next rheumatoid arthritis patient, we have a trial that could help these people,'" Kingsley explains. "As a result we become high enrollers in all of our trials."

• Give referral sources what they need: "We tell our referral sources that we will never bounce a patient back to them," Kingsley says. "If the ER doctor sends a patient to us, and that patient doesn't fit in our trial, then we take care of the patient anyway — for free."

This is a relief to ER physicians and others because they need to know that when they make a referral the patient will be seen and treated. Otherwise, if the patient was referred to a research site and not enrolled in the study, then the patient might end up back at the ER for treatment of an acute episode of the same disease or problem, Kingsley explains.

Once ER physicians make a referral to Southeast Regional Research Group, they know the patient won't return to their facility with the same untreated condition.

All referral patients are given whatever medical services they need, Kingsley says.

"We think it's a huge incentive that we won't send patients back," Kingsley says.

ER physicians always are wondering whether their patients have enough money to afford a return trip to a doctor or to purchase the prescription that will heal them, he explains.

"An ER physician might see the same patient in three nights from now if the person doesn't get the prescription filled," Kingsley says. "But Southeast Regional Research Group is open 24/7, so if they send the patient here, they know the patient will be taken care of for free, and it allows the ER doctor to breathe a sigh of relief."

Even patients who can't be enrolled are treated.

For example, Southeast Regional Research Group conducts many IV infusion studies for antibiotics, and referral sources are accustomed to sending over patients for these trials.

"So right now we're in between trials for IV antibiotics, but we were referred four patients who are receiving IV antibiotics, and the cost is completely on us," Kingsley says. "We don't have a study right now, but we're maintaining our referral sources, and that is far more valuable to us than what it costs to give these patients free care."

The word is out in the community that the research organization has this policy, and this makes ER and other physicians more likely to refer patients to the group, he says.

• Improve quality of referrals: Screening potential participants often is very time-consuming and expensive, so the research group has a checklist that makes the process more efficient.

Referral sources are given a one-page checklist for each study. It has highlights of the inclusion/exclusion criteria, formed as questions that physicians quickly can check as either "yes" or "no."

"The ER doctor grabs that piece of paper, puts the person's name on top and checks 'yes, yes, yes,' or 'no, no, no,' signs it, and sends it back to us," Kingsley explains. "That's done before the patient ever meets us, and it becomes a part of the patient's record, showing that another physician thought that patient was appropriate for this trial."

The checklist helps to formalize the referral process, and it serves as a good reminder to physicians about the trial, he adds.

While some physicians don't like the checklist, most do, Kingsley says.

"We've learned which physicians are very friendly to us," Kingsley says. "There are three hospitals in Columbus, and we've received referrals from all of their emergency rooms."